Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT02469181 |
Other study ID # |
4-2014-0679 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
May 21, 2015 |
Est. completion date |
October 2024 |
Study information
Verified date |
June 2021 |
Source |
Yonsei University |
Contact |
Geu Ru Hong, M.D., Ph.D. |
Phone |
82-2-2228-8443 |
Email |
grhong[@]yuhs.ac |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The purpose of this study is to evaluate the impact of ERT on LV diastolic function and flow
in patients with Fabry's cardiomyopathy using diastolic stress echocardiography, LV vortex
flow and CMR.
Description:
1. Objectives -The purpose of this study is to evaluate the impact of ERT on LV diastolic
function and flow in patients with Fabry's cardiomyopathy using diastolic stress
echocardiography, LV vortex flow and CMR.
2. Primary / Secondary Endpoint 1) Primary endpoint
- Changes of peak exercise E/E' by diastolic stress echocardiography (RECAP-F STRESS
trial) and LV vortex flow parameters (RECAP-F FLOW trial) at 1 year follow up.
2) Secondary endpoint
- Changes of extracellular volume by CMR(T1 mapping) at 1 year follow up (RECAP-F
trial) ② Evaluation of the degree of the resting LV diastolic function ③ Other
echo-parameters; LV mass index at baseline, 1 year follow up, reduction of peak
exercise E/E prime at 1 year follow up
- Changes of quality of life using questionnaire ⑤ Change of peak VO2, exercise
time, AT by diastolic stress echocardiography at 1 year follow up ⑥ Change in
T1 baseline(myo, ms) & T1 baseline(blood, ms) T1 postcontrast(myo, ms) & T1
baseline(blood, ms) by CMR
3. Study Methods 1) Study Design : 28 patients with newly diagnosed genetically confirmed
Anderson-Fabry's disease will undergo diastolic stress echocardiography, LV vortex flow
analysis, and cardiac MRI before enzyme replacement therapy(ERT) (baseline study) and
after 1 year of treatment with agalsidese beta at the dose of 1mg/kg (follow-up study).
2) Study procedures : Examinations as described below will be done before ERT and 1 year
later